Stoma®
Stomaform-mirror and probe handle, hollow, stainless, Ø 10mm
29manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (6), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Instrument, Dental
Record
| Listed by | Storz AM Mark Gmbh, Germany |
|---|---|
| FDA product code | EJB |
| Device type | Handle, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-27 |
| Record revised | 2023-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14515.03 | In distribution | |
| 14514.03 | In distribution | |
| 5110.20 | In distribution | |
| 5118.10 | In distribution | |
| 14520.03 | In distribution | |
| 5114.25 | In distribution | |
| 15112.25 | In distribution | |
| 13338.00 | In distribution | |
| 13389.00 | In distribution | |
| 14510.00 | In distribution | |
| 15108.10 | In distribution | |
| 5117.10 | In distribution | |
| 7514.13 | In distribution | |
| 5318.07 | In distribution | |
| 7514.03 | In distribution | |
| 5110.00 | In distribution | |
| 5104.00 | In distribution | |
| 7513.15 | In distribution | |
| 14516.03 | In distribution | |
| 5116.10 | In distribution | |
| 13322.02 | In distribution | |
| 5110.10 | In distribution | |
| 5109.00 | In distribution | |
| 5107.00 | In distribution | |
| 13325.00 | In distribution | |
| 5115.10 | In distribution | |
| 14512.00 | In distribution | |
| 15108.00 | In distribution | |
| 13322.01 | In distribution | |
| 5110.30 | In distribution | |
| 13322.07 | In distribution | |
| 15109.10 | In distribution | |
| 13339.00 | In distribution | |
| 4520.03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 121 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 89 |
| Premium Plus | Premium Plus International Limited | 83 |
| Surgical Kit | Shinhung MST Co., Ltd. | 78 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 59 |
| Bioclear Diamond Wedge | Bioclear Matrix Systems, LLC | 50 |
| Hygitech | Hygitech | 47 |
| Plasdent | Plasdent Corp. | 37 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 34 |
| LMDental | LM-Dental | 33 |
| Henry Schein | Henry Schein, Inc. | 32 |
| ACE | Ace Surgical Supply Co., Inc. | 28 |
Showing 12 of 221. All products under Handle, Instrument, Dental
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.